BEUDAMED
    25 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code NPW·March 27, 2026

    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JSO·November 9, 2022

    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JSO·November 9, 2022

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·December 28, 2020

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Recall
    Open, Classified ·New Standard Device Inc·Product code HXC·August 14, 2019

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Recall
    Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

    FDA Recall
    Open, Classified ·Koven Technology, Inc.·Product code DPW·March 4, 2026

    GEM FLOW COUPLER Monitor, PN 5156-00000-011

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DPW·June 19, 2023

    FloPatch FP120, REF: FP120-FOT01-005

    FDA Recall
    Open, Classified ·Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada·Product code DPW·August 7, 2025

    Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

    FDA Recall
    Open, Classified ·Medistim Asa Okernveien·Product code DPW·September 26, 2025

    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Recall
    Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·April 2, 2024

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·September 18, 2025

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code QAV·August 7, 2024

    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024

    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

    FDA Recall
    Open, Classified ·Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand·Product code ETD·November 24, 2024